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Trial record 28 of 593 for:    binge eating disorder

Dasotraline Binge Eating Disorder Extension Study

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ClinicalTrials.gov Identifier: NCT02684279
Recruitment Status : Active, not recruiting
First Posted : February 17, 2016
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Sunovion

Brief Summary:
Binge Eating Disorder Extension Study.

Condition or disease Intervention/treatment Phase
Binge Eating Disorder Drug: Dasotraline Phase 3

Detailed Description:
This is a Phase 3, 12 month, multicenter, open-label, flexibly-dosed, safety study in adults with Binge Eating Disorder.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: open-label
Primary Purpose: Treatment
Official Title: An Open-label, Flexibly-dosed, Multicenter, Extension Study of Dasotraline to Evaluate Long-term Safety and Tolerability in Adults With Binge-eating Disorder
Actual Study Start Date : February 29, 2016
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dasotraline
4, 6, 8 mg flexibly dosed
Drug: Dasotraline
Dasotraline 4, 6, 8 mg flexibly dosed once daily




Primary Outcome Measures :
  1. The incidence of overall Adverse Events, Serious Adverse Events (SAEs), and AEs (or SAEs) leading to discontinuation [ Time Frame: Baseline to 12 Months ]
    The incidence of overall Adverse Events, Serious Adverse Events (SAEs), and AEs (or SAEs) leading to discontinuation

  2. The frequency and severity of suicidal ideation and suicidal behavior using the Columbia Suicide Severity Rating Scale (C SSRS) [ Time Frame: Baseline to 12 Months ]
    The frequency and severity of suicidal ideation and suicidal behavior using the Columbia Suicide Severity Rating Scale (C SSRS)


Secondary Outcome Measures :
  1. Clinical laboratory evaluations (serum chemistry, hematology, urinalysis) [ Time Frame: Baseline to 12 Months ]
    Clinical laboratory evaluations (serum chemistry, hematology, urinalysis)

  2. Clinical evaluations (vital signs including orthostatic effects, and 12 lead ECGs) [ Time Frame: Baseline to 12 Months ]
    Clinical evaluations (vital signs including orthostatic effects, and 12 lead ECGs

  3. Frequency and severity of suicidal ideation and suicidal behavior using the C-SSRS [ Time Frame: Baseline to 12 Months ]
    Frequency and severity of suicidal ideation and suicidal behavior using the C-SSRS

  4. Percent change in body weight [ Time Frame: Baseline to 12 Months ]
    Percent change in body weight

  5. Percent change in Body Mass Index [ Time Frame: Baseline to 12 Months ]
    Percent change in Body Mass Index

  6. Change in fasting lipid panel (triglycerides, total cholesterol, high-density lipoprotein [HDL] cholesterol, and low-density lipoprotein [LDL] cholesterol) [ Time Frame: Baseline to 12 Months ]
    Change in fasting lipid panel (triglycerides, total cholesterol, high-density lipoprotein [HDL] cholesterol, and low-density lipoprotein [LDL] cholesterol)

  7. Change in hemoglobin A1c levels [ Time Frame: Baseline to 12 Months ]
    Change in hemoglobin A1c levels

  8. Change in fasting glucose levels [ Time Frame: Baseline to 12 Months ]
    Change in fasting glucose levels

  9. Change in the symptoms of withdrawal from dasotraline from Week 52/EOT as measured by: Cocaine Selective Severity Assessment (CSSA) total score at Weeks 53, 54, and 55 [ Time Frame: Up to 55 Weeks ]

    Change in the symptoms of withdrawal from dasotraline from Week 52/EOT as measured by:

    Cocaine Selective Severity Assessment (CSSA) total score at Weeks 53, 54, and 55


  10. Change in the symptoms of withdrawal from dasotraline from Week 52/End of treatment (EOT) as measured by: - Discontinuation-Emergent Signs And Symptoms (DESS) total score at Weeks 53, 54, and 55 [ Time Frame: Up to 55 Weeks ]

    Change in the symptoms of withdrawal from dasotraline from Week 52/End of treatment (EOT) as measured by:

    - Discontinuation-Emergent Signs And Symptoms (DESS) total score at Weeks 53, 54, and 55


  11. Change in the symptoms of withdrawal from dasotraline from Week 52/End of treatment (EOT) as measured by -Hamilton Anxiety Rating Scale (HAM A) total score at Weeks 53, 54, and 55 [ Time Frame: Up to 55 Weeks ]

    Change in the symptoms of withdrawal from dasotraline from Week 52/End of treatment (EOT) as measured by

    -Hamilton Anxiety Rating Scale (HAM A) total score at Weeks 53, 54, and 55


  12. Change in the symptoms of withdrawal from dasotraline from Week 52/End of treatment (EOT) as measured by: - Montgomery-Asberg Depression Rating Scale (MADRS) total score at Weeks 53, 54, and 55 [ Time Frame: Up to 55 Weeks ]
    Change in the symptoms of withdrawal from dasotraline from Week 52/End of treatment (EOT) as measured by: - Montgomery-Asberg Depression Rating Scale (MADRS) total score at Weeks 53, 54, and 55

  13. Change in Eating Disorder Examination Questionnaire (EDE Q) modified global score and subscale scores (restraint, shape, concern, weight concern), and Items 4-6 scores [ Time Frame: Baseline to 12 Months ]
    Change in Eating Disorder Examination Questionnaire (EDE Q) modified global score and subscale scores (restraint, shape, concern, weight concern), and Items 4-6 scores

  14. Change in Binge Eating Clinical Global Impression-Severity (BE-CGI S) score [ Time Frame: Baseline to12 Months ]
    Change in Binge Eating Clinical Global Impression-Severity (BE-CGI S) score

  15. Change in Sheehan disability Scale (SDS) total score and subscale scores (school/work disability, social life disability, and family life disability) [ Time Frame: Baseline to 12 Months ]
    Change in Sheehan disability Scale (SDS) total score and subscale scores (school/work disability, social life disability, and family life disability)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 56 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completion of the treatment period of a dasotraline core study (ie, SEP360 221 or SEP360-321) for the treatment of BED.
  • Subject has agreed to participate by providing written informed consent and is willing and able to comply with the protocol, in the opinion of the investigator.
  • Subject has not taken any medication other than the study drug for the purpose of controlling BED symptoms during the core study.
  • Female subject must have a negative urine pregnancy test at open label (OL) Baseline; females who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test.
  • Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to use an effective and medically acceptable form of birth control (see Section 22, Appendix III) throughout the study period. Note: Continued use of an effective and medically acceptable form of birth control is recommended for 30 days after study completion.
  • Subject is judged by the investigator to be suitable for participation in a 12 month clinical trial involving open-label dasotraline treatment.
  • Subject can read well enough to understand the informed consent form and other subject materials.

Exclusion Criteria:

  • Subject is considered by the investigator to be at imminent risk of suicide, injury to self or to others, or damage to property.
  • Subject is considered a suicide risk in the investigator's opinion or has any previous history of suicide attempt within the past 12 months.
  • Subject answers "yes" to "suicidal ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C SSRS assessment at OL Baseline. Subjects who answer "yes" to this question must be referred to the Investigator for follow up evaluation.
  • Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory tests that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
  • Subject has a positive urine drug screen (UDS) or breath alcohol test at OL Baseline.
  • Subject is breastfeeding.
  • Subject is at high risk of non-compliance in the investigator's opinion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684279


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Sponsors and Collaborators
Sunovion
Investigators
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Study Director: Dasotraline Medical Director Sunovion

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Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT02684279     History of Changes
Other Study ID Numbers: SEP360-322
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
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Disease
Feeding and Eating Disorders
Bulimia
Binge-Eating Disorder
Pathologic Processes
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms